QC Specialist III

QC Specialist III Kite Pharma - 3.4 El Segundo, CA Job Details Full-time $107,185 - $138,710 a year 1 day ago Benefits Health insurance Dental insurance Paid time off Vision insurance Life insurance Qualifications Bachelor's degree Full Job Description Job Description We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description This position is for Sun-Wed Swing Shift, 12:00PM to 10:30PM.

Primary Job Responsibilities:

Lead (or support) projects in Analytical Method development, validation, and method technology transfer in areas of Flow Cytometry, ddPCR and Bioassays consisting of cell culture and ELISA. Lead (or support) studies, implementation of new processes or technologies, and revise or review SOPs, qualification/validation protocols and reports. Perform analytical assays in techniques such as Flow cytometry, ddPCR, cell culture and

ELISA GMP

environment. Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays. Support audit activities and regulatory inspections by assisting in preparation of dossiers and data packages for interactions between Kite and Regulatory agencies, if needed. Review proposed changes to systems, procedures, methods and submissions to regulatory agencies, as appropriate. Lead investigations regarding out of specification (OOS) results, Out of Trend (OOT) events and any other unexpected event related to the laboratory. Support generation of trending charts for monitoring method performance, product quality, invalid rate and/or stability. Perform QC sample receipt, processing, and distribution for testing and storage as well as track inventory of lab supplies and materials. Monitor the GMP systems currently in place to ensure compliance with documented policies Support generation of CoAs for product release as needed. Mentor and support on the job training for junior staff.

Specific Education & Experience Requirements:

5+ years of relevant experience and a BS or BA. 3+ years of relevant experience and a MS. Prior experience in pharmaceutical industry is preferred. The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans•. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.

NOTICE:

EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.